CLINICAL TRIALS PROFILE FOR APIDRA

All Clinical Trials for APIDRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00115570 ↗	Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents	Completed	Sanofi	Phase 3	2005-04-01	The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.
NCT00135083 ↗	Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus	Completed	Sanofi	Phase 3	2004-08-01	The purpose of this study is to show the non-inferiority of insulin glulisine administered with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c (HbA1c), from baseline to study week 24.
NCT00135096 ↗	Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin	Completed	Sanofi	Phase 3	2004-08-01	The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.
NCT00311077 ↗	Insulin Glulisine in Healthy Lean and Obese Subjects	Completed	Sanofi	Phase 1	2004-04-01	Primary objective - To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™. Secondary objective - To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.
NCT00384085 ↗	Insulin Glargine "All to Target" Trial	Completed	Sanofi	Phase 4	2006-05-01	The primary objectives were: - To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%) at Week 60 - To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c
NCT00394407 ↗	Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes	Completed	Sanofi	Phase 4	2005-09-01	High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).

Clinical Trial Conditions for APIDRA

Condition Name

Condition Name for APIDRA
Intervention	Trials
Diabetes Mellitus, Type 1	8
Diabetes Mellitus, Type 2	7
Type 2 Diabetes	6
Type 2 Diabetes Mellitus	6

Condition MeSH

Condition MeSH for APIDRA
Intervention	Trials
Diabetes Mellitus	42
Diabetes Mellitus, Type 2	23
Diabetes Mellitus, Type 1	17
Hyperglycemia	7

Clinical Trial Locations for APIDRA

Trials by Country

Trials by Country for APIDRA
Location	Trials
United States	131
Germany	6
France	3
Egypt	3
Mexico	3

Trials by US State

Trials by US State for APIDRA
Location	Trials
California	9
Georgia	8
Florida	7
Minnesota	7
Washington	6

Clinical Trial Progress for APIDRA

Clinical Trial Phase

Clinical Trial Phase for APIDRA
Clinical Trial Phase	Trials
Phase 4	28
Phase 3	10
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for APIDRA
Clinical Trial Phase	Trials
Completed	42
Terminated	6
Unknown status	5

Clinical Trial Sponsors for APIDRA

Sponsor Name

Sponsor Name for APIDRA
Sponsor	Trials
Sanofi	37
Emory University	5
Halozyme Therapeutics	4

Sponsor Type

Sponsor Type for APIDRA
Sponsor	Trials
Industry	45
Other	39
U.S. Fed	1

APIDRA Market Analysis and Financial Projection

APIDRA (Insulin Glulisine): Clinical Trials, Market Analysis, and Projections

Introduction to APIDRA

APIDRA, also known as insulin glulisine, is a rapid-acting insulin analog developed by Sanofi. It was launched in 2005 in European countries and in 2006 in the United States. APIDRA is designed to help manage blood sugar levels in patients with type 1 and type 2 diabetes[3][4].

Clinical Trials Overview

Efficacy and Safety Studies

Clinical trials for APIDRA have been conducted to evaluate its efficacy and safety in various patient populations. A notable study involved 316 patients with type 2 diabetes who were previously uncontrolled on Lantus (insulin glargine) and oral antidiabetic drugs (OADs). Patients were randomized to receive APIDRA either at breakfast or at the main mealtime. The study aimed to achieve target glucose levels of 2-hour postprandial glucose (PPG) ≤135 mg/dL and fasting blood glucose (FBG) ≤100 mg/dL without hypoglycemia. The results showed significant reductions in A1C levels for both groups[1].

Adverse Reactions and Safety Profile

In controlled clinical trials, potential systemic allergic reactions were reported in 4.3% of patients receiving APIDRA. Common adverse reactions include hypoglycemia, allergic reactions, injection site reactions, and lipodystrophy. The safety profile of APIDRA has been evaluated in various clinical settings, including its use in insulin infusion pumps[4].

Use in Insulin Pumps

APIDRA has been tested with several insulin pumps, including Disetronic and MiniMed models. It is recommended to change the insulin in the reservoir and the infusion sets at least every 48 hours to maintain efficacy and safety[4].

Market Analysis

Current Market Landscape

The type 2 diabetes market is highly competitive and mature, with a significant presence of generic drugs. However, the market is expected to grow substantially due to the increasing prevalence of diabetes and the introduction of novel branded drugs. APIDRA, as a rapid-acting insulin analog, competes in this crowded market by offering a quick onset of action and flexibility in dosing[3][5].

Sales Forecast and Market Projections

From 2012 to 2022, the sales forecast for APIDRA indicated growth, particularly in key markets such as the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, India, and China. Despite the competitive landscape, APIDRA's sales were driven by its efficacy and the growing demand for diabetes management therapies[3].

Market Trends and Drivers

The global type 2 diabetes market is expected to almost double between 2015 and 2025, driven by the increasing prevalence of the disease and the adoption of combination therapies. Rapid-acting insulins like APIDRA benefit from this trend, although the market is also seeing a shift towards other classes of drugs such as GLP-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter-2 inhibitors (SGLT-2Is), which are expected to grow at a CAGR of 12.2% and 13.0%, respectively[5].

Competitive Assessment

Competitive Landscape

The type 2 diabetes market is characterized by a late-stage pipeline with many me-too drugs. However, novel branded drugs and combination therapies are gaining traction. APIDRA competes with other rapid-acting insulins and faces competition from emerging drug classes. A detailed SWOT analysis highlights APIDRA's strengths in its rapid onset of action and flexibility, but also notes its weaknesses in a crowded market with strong generic competition[3][5].

Strategic Positioning

To stay competitive, Sanofi, the manufacturer of APIDRA, must focus on strategic positioning, including identifying products with robust return potential, understanding the changing competitive landscape, and planning effective M&A and partnership strategies. The company must also capitalize on the growing demand for diabetes management therapies and differentiate APIDRA through its clinical benefits and patient-centric approach[3].

Future Outlook and Projections

Market Growth Projections

The type 2 diabetes market is projected to experience significant growth between 2015 and 2025. APIDRA, as part of this market, is expected to benefit from the increasing prevalence of diabetes and the need for effective glucose management. However, its growth will be influenced by the rise of other drug classes and the competitive dynamics of the market[5].

Technological and Regulatory Trends

Technological advances in insulin delivery systems and ongoing regulatory changes will also impact APIDRA's market position. The trend towards diversifying the supply chain and increasing domestic API manufacturing capabilities, as seen in the broader pharmaceutical industry, may also affect the production and distribution of APIDRA[2].

Key Takeaways

• Clinical Efficacy: APIDRA has demonstrated significant reductions in A1C levels in clinical trials, particularly in patients with type 2 diabetes.
• Safety Profile: The drug has a well-documented safety profile, with common adverse reactions including hypoglycemia and allergic reactions.
• Market Competition: APIDRA operates in a highly competitive type 2 diabetes market, with growth driven by increasing disease prevalence and the adoption of novel therapies.
• Future Outlook: The market is expected to grow, but APIDRA's success will depend on its ability to compete with emerging drug classes and technological advancements.

FAQs

What is APIDRA and how does it work?

APIDRA, or insulin glulisine, is a rapid-acting insulin analog that helps manage blood sugar levels in patients with type 1 and type 2 diabetes by mimicking the natural insulin response after meals.

What are the common adverse reactions associated with APIDRA?

Common adverse reactions include hypoglycemia, allergic reactions, injection site reactions, and lipodystrophy.

Can APIDRA be used in insulin pumps?

Yes, APIDRA has been tested and approved for use with several insulin pumps, including Disetronic and MiniMed models.

What is the projected market growth for APIDRA and the type 2 diabetes market?

The type 2 diabetes market is expected to almost double between 2015 and 2025, driven by increasing disease prevalence and the adoption of novel therapies. APIDRA is expected to benefit from this growth, although its market share will be influenced by competition from other drug classes.

How does APIDRA compare to other rapid-acting insulins in the market?

APIDRA competes with other rapid-acting insulins but is differentiated by its quick onset of action and flexibility in dosing. However, it faces strong competition from emerging drug classes like GLP-1RAs and SGLT-2Is.

What are the key drivers of growth for the type 2 diabetes market?

The key drivers include the increasing prevalence of diabetes, physicians' efforts to delay disease progression, and the adoption of combination therapies and novel branded drugs.

Sources

1. Apidra® (insulin glulisine injection) 100 Units/mL - Apidra. Apidra.
2. Active Pharmaceutical Ingredients Market Forecast Report. GlobeNewswire.
3. Research and Markets: Apidra (Type 2 Diabetes) - Forecast and Market Analysis to 2022. Business Wire.
4. APIDRA® (insulin glulisine injection), for subcutaneous use. Sanofi US.
5. PharmaPoint: Type 2 Diabetes – Global Drug Forecast and Market Analysis to 2025. GlobalData.